BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUFOCUS

    MDR report key: 6063224 · Received October 26, 2016

    Report

    Report Number
    MW5065656
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    August 17, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ACUFOCUS
    Product Code
    LQE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    KAMRA INLAY PLACED IN RIGHT EYE ON (B)(6) 2016, PT PRESENTED WITH CORNEAL ABRASION/INFECTION. ON (B)(6) 2016, PT PRESENTED WITH WORSENING OF PAIN INFECTION, VISION DECREASED PLACED ON FORTIFIED TOBRAMYCIN AND VANCOMYCIN DROPS. ON (B)(6) 2016 SIGHT THREATENING INFECTION, KAMRA INLAY REMOVED, CULTURES DONE, NO GROWTH ON CULTURES. PT WENT (ON HER OWN) TO ANOTHER DOCTOR FOR SECOND OPINION/TREATMENT. ON (B)(6) 2016 INFO FROM THE OTHER PHYSICIAN SHOWS THEIR CULTURES REVEALING STAPH AUREUS, CANDIDA, ENTEROBACTER, STREP AGALACTIAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709664 ACUFOCUS KAMRA INLAY LQE ACUFOCUS A553-0415

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other